Biopsy device arming mechanism

ABSTRACT

A biopsy device for percutaneous tissue removal includes an elongated housing having an operational axis, a stylet hub slidably mounted in the housing, where the stylet hub is movable relative to the housing between a proximal, armed position, and a distal, fired position, the stylet hub having a stylet strike, a cannula hub slidably mounted in the housing alongside the stylet hub, and a spring-biased arming member. The cannula hub is movable relative to the housing between a proximal, armed position, and a distal, fired position. The arming member is moveably mounted to the housing proximal of the respective stylet and cannula hubs, and configured for manually-actuated movement from a relaxed, extended position to a loaded, compressed position to define a compressive arming stroke. The biopsy device also includes an arming member biasing spring that restores the arming member from the compressed position to the extended position.

RELATED APPLICATION DATA

The present application is a continuation of pending U.S. patentapplication Ser. No. 14/555,531, filed Nov. 26, 2014, which claims thebenefit under 35 U.S.C. § 119 to U.S. Provisional Application Ser. Nos.61/953,570, filed Mar. 14, 2014, and 61/909,234, filed Nov. 26, 2013.The foregoing applications are hereby incorporated by reference into thepresent application in their entirety.

FIELD

The present disclosure generally relates to the field of tissue samplingand harvesting. More specifically, the disclosure relates to biopsyneedle sets and devices.

BACKGROUND

In the practice of diagnostic medicine, it is often necessary ordesirable to perform a biopsy, or to sample selected tissue from aliving patient for medical evaluation. Cytological and histologicalstudies of the biopsy sample can then be performed as an aid to thediagnosis and treatment of disease. Biopsies can be useful in diagnosingand treating various forms of cancer, as well as other diseases in whicha localized area of affected tissue can be identified.

Biopsies are routinely performed on tissue using a needle set, whichtypically includes an inner needle/stylet with a pointed tip and anaperture/notch defined near its distal end. The stylet is slidablydisposed within an outer cannula so that the notch can be alternatelyexposed or covered. Typically, a hub is connected to the proximal end ofeach needle. Such needle sets are used with or incorporated in variousforms of biopsy devices, such as the single action and double actionbiopsy devices.

Currently, there are several soft tissue biopsy devices which areclassified as Spring Loaded Core biopsy devices. These all share thecharacteristics of employing springs to create force and movement inneedle cannulas axially to selectively remove a sample of the tissue.These devices are required to have the springs loaded, or armed,manually to compress and lock the springs in a compressed state toprepare for actuating the device. As the device is actuated the cannulamoves rapidly forward to cut through tissue adjacent to the needle andcontain it within the cannula until it is retrieved by the clinician.

Many of the current devices available are deficient in that they aredifficult for users to arm and actuate the device and otherwise use thedevice due to ergonomic factors. For example it is highly desired forthe user (usually a physician) to arm the device using a single handsince the other hand is frequently needed to hold other devices. Manycurrent devices cannot be armed easily with a single hand. In addition,many users with smaller than average hands may not be able to armdevices designed for larger hands and also may not be able to arm thedevice with one hand. Many of the devices are designed so that a singlefinger is used to arm the device which can be difficult and to dobecause of the force required. Since the action of arming the device isthe same action required to withdraw the outer cannula to access theexcised tissue sample, the “arming motion” is done three times persample (twice to arm the device and once to access the excised tissuesample). When the arming motion cannot be done with a single hand orwithout difficulty, it presents a significant challenge to the userduring the medical procedure. Other devices require compression ofelements with the fingers in an extended state which makes it difficultbecause it is not possible to generate as much force in an extendedstate as it is with the hand un-extended (e.g. with the hand held in a“C” shape). Some devices have arming features which spring forward andmay hit and pinch parts of the hand or patient. In addition, it may beadvantageous to arm the device using other surfaces besides the hand anduse the muscles of the arm instead to more easily compress the springs.

Another issue is the inability to actuate (i.e., fire) the device easilyin-use. Some devices have buttons that cannot be reached easily orrequire a motion that may disturb the placement of the device which maydecrease accuracy of the tissue targeting. The actuation button can bedifficult to depress due to the location of the button and/or the forcerequired. In addition it is often desired to have the ability to acquirethe tissue in two distinct steps for safety and efficacy reasons. Inthis case two or more buttons may be needed. Current devices havebuttons that may be mistaken from each other due to similar shape and/orposition. Current actuation buttons may be unintentionally depressedduring handling because they are protruding and can be depressed withpressure coming from unintended contact with a hand surface and/or canbe depressed easily with low force. A misfire can be unsafe orcompromise the acquisition of tissue.

Current spring loaded core biopsy devices have spring loaded memberswhich propel the needle element forward. The members are stopped whenthey impact a flat, rigid surface in the device casing by design. Thiscontrols the stroke and final position of the needle elements. Althoughthis is effective in positioning and stopping the needle at the desiredlocation, it results in the energy from the needle impact beingconverted to sound energy which is propagated to the casing of thedevice. This sound can be relatively loud and often startling to thepatient. Most devices make a loud snap noise when actuated which can bestartling to the patient who may already be in a distressed state due tothe procedure. If the patient is startled not only is there the anxietyinvolved, but if the patient moves as a result of being startled, thesafety and accuracy of the procedure may be affected.

Current devices may be configured so that the tissue aperture isoriented in a position that is not optimized for how the device isusually held. Many users will hold the device so that their hands are ina neutral position. In this position the thumb is on the side of thedevice in position to depress the button to actuate the device. Whenheld in this position, the aperture opening is preferred to be facing upby many physicians; many devices have the aperture open to thehorizontal plane while held in this position.

Needle axial concentricity to hand piece is yet another issue. Currentdevices have a needle which is asymmetric to the hand piece axis. Thisforces the operator to make an unnatural eccentric rotation of the wristduring positioning and acquisition of tissue to maintain the intended,centered position of the needle.

Arming feature design is still another issue. Current devices havearming features that protrude laterally external to the device. Thesefeatures interfere with the patient's body during procedures causingdiscomfort and a limited range of motion.

Further, some current devices do not have a needle gauge size colorindication for the operator to easily select or confirm proper needlesize for the procedure.

SUMMARY

In one embodiment, a biopsy device for percutaneous tissue removalincludes an elongated housing having an operational axis, a stylet hubslidably mounted in the housing, where the stylet hub is movablerelative to the housing between a proximal, armed position, and adistal, fired position, the stylet hub having a stylet strike, a cannulahub slidably mounted in the housing alongside the stylet hub, and aspring-biased arming member. The cannula hub is movable relative to thehousing between a proximal, armed position, and a distal, firedposition. The arming member is moveably mounted to the housing proximalof the respective stylet and cannula hubs, and configured formanually-actuated movement from a relaxed, extended position to aloaded, compressed position to define a compressive arming stroke. Thebiopsy device also includes an arming member biasing spring thatrestores the arming member from the compressed position to the extendedposition.

In a single or multiple embodiments, the stylet hub has a stylet strikelaterally offset from the operational axis in a first lateral direction,and the cannula hub has a cannula strike laterally offset from theoperational axis in a second lateral direction, and proximal of thestylet strike, when the stylet hub and cannula hub are in the firedposition. The biopsy device may also include a resilient arming shaftcoupled to the arming member and extending along the operational axis.The resilient shaft is integrally formed with or otherwise attached toan arming shaft catch. The arming shaft catch, when the stylet hub andcannula hub are each in the fired positions, is configured to engage thecannula strike, upon a first compressive arming stroke, to therebydeflect the arming shaft catch away from the operational axis such thatthe arming shaft catch clears the stylet strike and moves the cannulahub to the armed position. The arming shaft catch is also configured toengage the stylet strike, upon a second compressive arming stroke, tomove the stylet hub to the armed position. The arming shaft catch mayinclude a first recess having an angled engagement surface configured toreceive the cannula strike during the first compressive arming stroke,and a second recess having an angled engagement surface configured toreceive and engage the stylet strike during the second arming stroke.

In a single or multiple embodiments, the biopsy device includes a stylethaving a proximal end portion coupled to the stylet hub and a tissuepiercing distal portion extending beyond the distal end of the housing,and a cannula having a proximal end portion coupled to the cannula hub.The stylet hub is biased by a stylet hub biasing spring toward a distalend of the housing for driving the stylet in a distal direction relativeto the housing. The stylet hub may have a stylet hub catch forreleasably retaining the stylet hub in the armed position. The cannulamay be disposed coaxially around the stylet and may have an open-endeddistal portion extending beyond the distal end of the housing. Thecannula hub may be biased by a cannula hub biasing spring toward thedistal end of the housing for driving the cannula over the stylet in adistal direction relative to the housing. The cannula hub may have acannula hub catch for releasably retaining the cannula hub in the armedposition.

In a single or multiple embodiments, the housing includes a firstdeflectable wall portion, and when the stylet hub is in the armedposition, deflecting the first wall portion releases the stylet hubcatch, causing the stylet hub spring to propel the stylet hub to thefired position. The housing may also include a second deflectable wallportion of the housing, and when the cannula hub is in the armedposition, deflecting the second wall portion releases the cannula hubcatch, causing the cannula hub spring to propel the cannula hub to thefired position. The second deflectable wall portion may be separatedfrom the first deflectable wall portion so that deflection of the firstwall portion does not release the cannula hub catch, and deflection ofthe second wall portion does not release the stylet hub catch. Thebiopsy device may include a first control pushbutton including orotherwise coupled to the first deflectable wall portion, and a secondcontrol pushbutton coupled to the housing at least partially over thefirst wall portion and at least partially over the second wall portion.In some embodiments, when the stylet hub and cannula hub are each in thearmed position, depressing the second control button sequentiallydeflects the first and second wall portions, thereby sequentiallyreleasing the stylet hub catch and the cannula hub catch, to therebysequentially propel the respective stylet and cannula in the distaldirection. The second control push button may be attached or otherwisefixed to the first wall portion, and spaced apart from the second wallportion by a gap, such that depressing the second control buttonsubstantially simultaneously deflects the first wall portion while notdeflecting the second wall portion until the second control button isdepressed through the gap to make contact with the second wall portion.

In a single or multiple embodiments, the housing has a distal portionand a proximal portion, where the respective stylet and cannula hubs aredisposed within the distal portion of the housing, and the arming memberis mounted to the proximal portion of the housing, the arming memberhaving a surface configured to be depressed relative to the proximalportion of the housing to thereby move the arming member from theextended position into an interior of the proximal portion of thehousing for completing a compressive arming stroke. The arming membersurface may be depressed away from the distal portion of the housing forcompleting a compressive arming stroke. The arming member surface may besized and configured for being manually depressed into the proximalportion of the housing using one or more fingers of a single hand. Thehousing may have a proximal end surface sized and configured for beingretained against a palm of the single hand when the arming membersurface is depressed, such that a compressive arming stroke can be madeby backstopping the proximal end surface in the palm and squeezing thearming member into the proximal housing portion using the at least onefinger, respectively, of the hand.

In a single or multiple embodiments, the arming member surface isdepressed towards the distal portion of the housing for completing acompressive arming stroke. The arming member surface may include adistal end surface of the device, and the housing may be sized andconfigured for being grasped by a single hand, such that a compressivearming stroke can be made by grasping the housing using a single handand pressing the proximal end of the housing against a rigid surface tothereby depress the arming member into the proximal housing portion.

Other and further aspects and features of embodiments of the disclosedinventions will become apparent from the ensuing detailed description inview of the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of embodiments of thedisclosed inventions, in which similar elements are referred to bycommon reference numerals. These drawings are not necessarily drawn toscale. In order to better appreciate how the above-recited and otheradvantages and objects are obtained, a more particular description ofthe embodiments will be rendered, which are illustrated in theaccompanying drawings. These drawings depict only typical embodiments ofthe disclosed inventions and are not therefore to be considered limitingof its scope.

FIGS. 1A, 1B, 2A and 2B are top views of three embodiments of springloaded core biopsy devices showing alternative arming motions.

FIG. 3 is a top view of the two embodiments depicted in FIG. 1 and aschematic view of a prior art device showing the differences in armingergonomics.

FIG. 4 shows top, side and perspective views of another embodiment of aspring loaded core biopsy device.

FIG. 5 shows three top views of the embodiment depicted in FIG. 2illustrating three stages in the arming motion.

FIGS. 6A-D are detailed top longitudinal cross-sectional (FIGS. 6A-C)and perspective (FIG. 6D) views of an embodiment of a spring loaded corebiopsy device.

FIGS. 7A-B are detailed perspective views of select components of anembodiment of a spring loaded core biopsy device, with other componentsomitted to show a rotatable aperture orientation control mechanism.

FIGS. 8A-B are end views of the embodiments depicted in FIGS. 1 and 2.

FIG. 9 is a perspective view of an embodiment of a spring loaded corebiopsy device, with the top of the body omitted for clarity.

FIG. 10 is a perspective view of the embodiment depicted in FIG. 4, withthe distal end of the needle omitted for clarity.

FIGS. 11A-D are top views of the top half of a body of a spring loadedcore biopsy device according to one embodiment.

FIGS. 12A-B are detailed side longitudinal cross-sectional views of thebody depicted in FIG. 11A. A button is attached to the body in FIG. 12B.

FIGS. 13A-C are detailed top views of the body depicted in FIG. 11Ashowing first and second levers.

FIGS. 14A-B are detailed bottom views of the body depicted in FIG. 1Ashowing first and second levers, and first and second catches.

FIG. 15 is a detailed top view of the body depicted in FIG. 11A showingfirst and second levers, and large firing button, with a portion of thebody shown in phantom for clarity.

FIGS. 16 and 17A-C are detailed top longitudinal cross-sectional view ofa spring loaded core biopsy device according to one embodiment atvarious steps of a first arming stroke.

FIGS. 18-20 are perspective views of an arming button and arming memberof a spring loaded core biopsy device according to two otherembodiments.

FIGS. 21A-25B are top longitudinal cross-sectional views of the springloaded core biopsy device depicted in FIG. 2 at various steps of a firstand a second arming stroke and at various levels (figures A vs. figuresB).

FIG. 26 is a top longitudinal cross-sectional view of an embodiment of aspring loaded core biopsy device according to another embodiment.

FIG. 27 is a side longitudinal cross-sectional view of the distal endsof a needle and a cannula of a spring loaded core biopsy deviceaccording to one embodiment.

FIGS. 28 and 29 are side longitudinal cross-sectional views of thedistal ends of a needle and a cannula of a spring loaded core biopsydevice according to another embodiment.

FIG. 30 is a side longitudinal cross-sectional view of the distal endsof a needle and a cannula of a spring loaded core biopsy deviceaccording to another embodiment.

FIG. 31 is side longitudinal cross-sectional view of the distal ends ofa needle and a cannula of a spring loaded core biopsy device accordingto still another embodiment.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, he terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

Various embodiments of the disclosed inventions are describedhereinafter with reference to the figures. It should be noted that thefigures are not drawn to scale. It should also be noted that the figuresare only intended to facilitate the description of the embodiments. Theyare not intended as an exhaustive description of the invention or as alimitation on the scope of the invention, which is defined only by theappended claims and their equivalents. In addition, an illustratedembodiment of the disclosed inventions needs not have all the aspects oradvantages shown. An aspect or an advantage described in conjunctionwith a particular embodiment of the disclosed inventions is notnecessarily limited to that embodiment and can be practiced in any otherembodiments even if not so illustrated. In order to better appreciatehow the above-recited and other advantages and objects are obtained, amore particular description of the embodiments will be rendered, whichare illustrated in the accompanying drawings. These drawings depict onlytypical embodiments of the disclosed inventions and are not therefore tobe considered limiting of its scope.

FIGS. 1A and 1B depict two spring loaded core biopsy devices 10according to two related embodiments. The device 10 depicted in FIG. 1Aincludes a distally-facing arming button (or “arming member”) 110 havinga distal surface 50. The device 10 also includes a body 16 having aproximal surface 52. In order to arm the device 10, a user grasps thedevice 10 with the proximal surface 52 of the body in the palm 54 of ahand 56 and fingers 58 of the hand 56 on the distal surface 50 of thearming button 110. Then, the user squeezes the arming button 110 twiceto arm the device 10 (as shown in FIG. 3). This motion can beaccomplished in multiple ways, including but not limited to those shownin FIG. 1A.

The device 10 depicted in FIG. 1B includes an arming lever 60 having adistal surface 50, and a body 16 having a proximal surface 52. In orderto arm the device 10, the user grasps the device 10 with a thumb 62 of ahand 56 on the proximal surface 52 of the body 16, and fingers 58 of thehand 56 on the distal surface 50 of the arming button 110. Then, theuser squeezes the arming button 110 twice to arm the device 10 (as shownin FIG. 3). This motion can be accomplished in multiple ways, includingbut not limited to those shown in FIG. 1B.

FIGS. 2A and 2B depict a spring loaded core biopsy device 10 accordingto another embodiment being armed using two different methods. Thedevice 10 includes a proximally-facing arming button 110 having aproximal surface 64. The device 10 also includes a body 16 having twoopposing longitudinal surfaces 66.

In the first method depicted in FIG. 2A, the user grasps the device 10with fingers 58 and palm 54 of a hand on respective opposinglongitudinal surfaces 66. The user holds the device 10 in either an “up”or “down” position relative to the user's thumb 62 (i.e., with thearming button 110 on respective different or same side of the user'shand from the user's thumb 62). FIG. 2A depicts a user holding a device10 in an “up” position. With a firm grip on the device 10, the userpresses the proximal surface 64 of the arming button 110 against anysupported (preferably flat) surface (not shown) to squeeze the armingbutton 110 twice to arm the device 10. The user can press the armingbutton 110 against the supported surface using any arm motion includingup, down or sideways.

In the second method depicted in FIG. 2B, the user grasps the device 10with fingers 58 and palm 54 of a hand on respective opposinglongitudinal surfaces 66. The user holds the device 10 in a “down”position relative to the user's thumb 62. The user presses the proximalsurface 64 of the arming button 110 using the thumb 62 of the hand 56 inwhich the device 10 is held to squeeze the arming button 110 twice toarm the device 10.

FIG. 4 depicts a spring loaded core biopsy device 10 is similar to thedevice 10 depicted in FIG. 1A. The difference between the devices 10depicted in FIGS. 4 and 1A is that the arming button 110 is rotated 90degrees in the device 10 depicted in FIG. 4. Rotation of the armingbutton 110 improves the fit of the proximal end of the device 10 in thepalm 54 because the depth of the arming button 110 is narrower than itswidth. This rotation of the arming button 110 may also be applied to thedevices 10 depicted in FIGS. 1B, 2A and 2B.

In the embodiments depicted in FIGS. 1A, 1B, 2A, 2B and 4, the innerneedle/stylet can be fired independently of the outer cannula bydepressing/actuating the smaller button 12, which is located toward themore proximal end of the device 10, after which the outer cannula can beadvanced by pressing the larger, more distally located button 14 toexcise tissue prolapsing into the aperture in the inner needle(described below). Alternatively, both the inner needle and the outercannula can be fired sequentially by only depressing the larger, moredistal button 14 (described below). To recover samples from theaperture, the user depresses/actuates the arming button 110 a singletime to expose the aperture and arm the outer cannula. To performfurther biopsies, the arming button 110 is depressed/actuated once more,and the device 10 is fully armed again and ready to acquire tissue.

Single Handed Usability:

In the device 10 depicted in FIG. 1A, the arming button 110 is adjacentto the proximal end of the device 10 and employs multiple fingers 58.Therefore, the device 10 can be armed or the cannula can be retracted toexpose tissue in the aperture with one hand 56 in a non-extendedposition using a compressive arming stroke, even for users with smallhands. This is in contrast to an extending arming stroke, which requirestwo hands. The device 10 is symmetric in two planes (two perpendicularplanes passing through the longitudinal axis of the device 10) for easyuse with both hands 56 and for easier access of the fingers 58 to thearming button 110. It can be easily transitioned from arming toacquiring/firing positions. The reach required for arming this device 10is only 2.25 or 1.3 inches compared to 4 inches or more of the existingdevices, as shown in FIG. 3. This difference is significant in relationto the span of the hand 56. This allows the device 10 to be armed with asingle hand 56 more easily because of improved control of the hand 56 inthe position shown in FIG. 1A, as well as the increased force/strengthgenerated by a hand 56 in this position. The features of the device 10depicted in FIG. 1A that facilitate single handed usability are alsopresent in the devices 10 depicted in FIGS. 1B and 4

In the device 10 depicted in FIGS. 2A and 2B, the arming button 110 isat the proximal end of the device 10, and is compressed into the body 16of the device 10 to arm the device 10, as shown in FIG. 5. Therefore,the device 10 can be armed by grasping the body 16 of the device 10 andpressing downward onto a supported surface (such as a table, or thephysician's leg; FIG. 2A), or by flipping the device 10 upside down anddepressing the arming button 110 with the thumb 62 (FIG. 2B). Pressingdownward with the muscles of the arm and shoulder as opposed to the muchsmaller muscles in the hand 56 gives the physician a mechanicaladvantage, making the device 10 significantly easier to arm thanexisting devices.

Using the device 10 this way, no shifting of the hand is necessarybetween arming and firing actions. Little to no reach (in terms offingers) is required for the user to arm the device 10. If the physicianchooses to arm using the thumb 62, the thumb 62 must reach approximatelyone inch to arm the device 10.

Actuating/Firing the Device:

The devices depicted in FIGS. 1A, 1B, 2A, 2B and 4 are actuated bydepressing one or two buttons 12, 14 in succession in order to releaseinternal components. As can be seen in FIGS. 13A-C and 15, the buttons12, 14 are depressed normal to the longitudinal axis of the device 10and in locations that are adjacent to fingers 58 and thumbs 62 of a hand56 when the device 10 is held by the hand 56 in a natural position.Depressing the buttons normal to the longitudinal axis also minimizesthe amount that the depressing motion will disturb the device 10location. FIGS. 13A-C and 15 also show the distinct size differencebetween the two buttons 12, 14 that serves as a non-visual indicator ofbutton function, as well as the raised case around the larger firingbutton 12 that reduces accidental actuation. The actuation mechanismsfor the devices 10 depicted in FIGS. 1A, 1B, 2A, 2B and 4 are the same.

Noise Reduction:

The device 10 depicted in FIGS. 1A, 1B, and 4 include features thatreduce the sound accompanying firing of the devices. These featuresinclude use of contacting surfaces that are not perpendicular to theaxis of travel of the needle and cannula, surfaces with more contactarea, flexible ribs, and sound energy absorbing materials in the body 16to muffle the sound, prevent propagation of the energy to the casing andto dampen or absorb the energy, as shown in FIGS. 6A-D and describedbelow.

Instead of two surfaces perpendicular to the axis of travel of theneedle and cannula contacting to stop distal travel of the needle andcannula, mating surfaces with conical, angled, hemispherical, parabolicor other non-planar shape can be used. These shapes increase the surfacearea and also reflect the energy of impact away from the casing,resulting in less sound from the casing.

Also, energy absorbing material including elastomeric, porous, foam, andpolymers with additives that absorb energy can be used to prevent loudsounds from being produced by the device. These materials can bedisposed in the device 10 so as to cushion the moving parts.Alternatively, the energy absorbing material can absorb sound energywithout coming in to contact with the moving parts. The absorbingmaterials can be used with or without the non-perpendicular surfacesdescribed above.

The noise produced by the actuation of the biopsy device 10 can beminimized using multiple features including, but not limited to, contactsurface geometry, bumpers, and materials. Case materials can be chosenthat will dampen a significant portion of the noise produced by impactof internal parts of the device 10. Bumpers can be disposed on impactsurfaces to further dampen the sound produced during operations. FIG. 6Ashows an example of how impact surfaces 68 that are angled with relationto the motion of impact (i.e., axis of travel of the needle and cannula)can reduce the amplitude of the transmitted impact force and subsequentnoise. As shown in FIG. 6B, a bumper 70 could be placed adjacent animpact surface 68 to minimize sound generated by impact forces. In fact,adding a bumper 70 can generate new impact surfaces 68′ that impact thebumper 70 instead of each other.

FIGS. 6C and 6D depict an embodiment of a biopsy device 10, andillustrate noise reduction features similar to those in the embodimentdepicted in FIG. 6A. In this embodiment, the interior of the biopsydevice body 16 includes flexible ribs 126 configured to stop therespective distal motion of the cannula carriage/hub 102 and the needlecarriage/hub 108. The ribs can be made from energy absorbing materials,including elastomers, porous materials, foam, and polymers withadditives.

The ribs 126 have a narrow cross-section. Therefore, they bend underaxial stress (from the distal motion of the cannula carriage/hub 102 andthe needle carriage/hub 108), thereby absorbing some of the energygenerated by the impact of the cannula carriage/hub 102 on the proximalends 128 of the ribs 126 at the point of impact 130. Absorbing theenergy of impact reduces the sound generated by that impact. The ribs126 also prevent propagation of the energy to the outside of the body16, further reducing the sound generated by the impact. In addition, theribs 126 configured to stop the distal motion of the cannulacarriage/hub 102 define a point of impact 130 that is not perpendicularto the axis of travel, thereby further absorbing the energy and reducingthe sound of impact. Although FIGS. 6C and 6D depict only one half ofthe body 16, both the top and bottom halves of the body 16 can includeribs 126.

In alternative embodiments, such as those depicted in FIGS. 2A, 2B and5, the device 10 can include one or more tethers (not shown) to stop themotion of the firing needle and/or cannula. Such tethers can includebraided wire, a recoiling elongate member and a dashpot.

Aperture Orientation:

It may be desirable for the aperture to face a direction other than theside of the device 10 with the firing buttons 12, 14. This direction canbe optimized based on the specific design for physician comfort orpreference. The device 10 can include an intuitive indication of thedirection of the aperture on the body 16 of the device 10.

The device 10 can also include a needle that rotates within the case ofthe device 10 to give the physician his or her choice of apertureorientations. FIGS. 7A and 7B depict a mechanism that would allow thephysician to change the orientation of the needle aperture. Thismechanism employs a rotatable collar 72 inside the device 10 that housesthe linear guides for the needle hub 108. The physician can rotate thiscollar 72 by means of a small exterior protrusion 74, lever, or slidingbutton. Springs may be attached to the needle hub 108 that will drivethe needle forward for firing, but will not restrict the needlesrotational alignment.

Axial Needle Concentricity:

The needle is centered within the device outer case in both the heightand width directions in order to facilitate ease of the physicianrotating the device around the needle axis while maintain the positionof the needle tip relative to a stationary target. This will allow theclinician to intuitively rotate the device for desired tissueacquisition aperture location while minimizing unwanted needle motionduring targeting. FIGS. 8A and 8B respectively show the embodimentsdepicted in FIGS. 1A-1B and 2A-2B from the distal end for visualizationof needle concentricity relative to the outer case of the device 10.

Arming Feature Design:

The surfaces of the features employed by the user to arm the internalmechanism are within the envelope of the outer case when viewed from anend of the device 10, as shown in FIGS. 8A and 8B. Because the devices10 do not include features that extend beyond the axial envelope of theouter case, the arming features of the devices will not unintentionallycontact a patient's body during a biopsy. Known devices, on the otherhand, often have wings or arms that protrude from the device near thebiopsy site surface on the patient, and can therefore unintentionallycontact the patient's body during a biopsy. Such unintentional contactcan be painful or uncomfortable for the patient, and can be a nuisancefor the physician attempting to place the device accurately. Eliminatingfeatures that could contact the patient results in a more comfortableexperience for both the patient and the physician during certainprocedures with difficult to reach lesions.

Distal Needle Support:

Adding inserts to the case mold or a small spacer to the assembly cancreate a more precise fit between the needle and the case by minimizingempty space around the needle at the most distal end of the case. Thisminimizes movement of the needle relative to the body of the device,thereby increasing the accuracy of the needle trajectory when fired.With a large amount of empty space between the needle and the case, theneedle can be shifted from the intended axis of trajectory by resistancefrom the tissue. Movement of the needle can also render it moredifficult to advance through tissue manually when targeting a lesion(before firing the needle). FIG. 9 show an insert/spacer 76 thatincludes an integrated noise reducing bumper component to serve a dualpurpose. Additionally, a spacer could extend past the most distal end ofthe case (not shown) and perform a tertiary function as a feature forthe needle sheath to press fit onto. This feature ensures that thesheath does not unintentionally slip off of the needle.

Actuation/Firing Mechanisms:

FIGS. 10-15 depict an embodiment of a biopsy device 10, and illustratethe actuation/firing buttons 12, 14 for firing the inner needle (notshown) and the outer cannula 104. The embodiment depicted in FIGS. 10-15may share some components or process steps with or be identical to otherembodiments described above. FIG. 10 depicts a biopsy device 10 having asmaller firing button 12 and a larger firing button 14. The smallerfiring button 12 is located more proximally on the device body 16 thanthe larger firing button 14.

FIGS. 11A-D depict a top half 16 a of a biopsy device body 16. FIGS. 11Aand 11C are top views of the top half 16 a of the biopsy device body 16,showing the exterior thereof. FIGS. 11B and 11D are bottom views of thetop half 16 a of the biopsy device body 16, showing the interiorthereof. For instance, the top half 16 a of the biopsy device body 16can snap together with a bottom half of the biopsy device body 16 (notshown) to form a biopsy device body 16. FIGS. 11C and 11D are enlargedviews of the distal portions of biopsy device body top half 16 a shownin FIGS. 11A and 11B to better illustrate the details related to thefiring buttons 12, 14.

As shown in FIG. 11C, the smaller firing button 12 is formed from thetop half 16 a of the biopsy device body 16. The smaller firing button 12is formed on a first lever 18 defined by three slots 20 a, 20 b and 20 cin the top half 16 a of the biopsy device body 16. Because of the threeslots 20 a, 20 b, and 20 c, the first lever 18 is pivotally movable intoand out of the plane defined by a top surface of the body top half 16 a.

Also shown in FIG. 11C, is a second lever 22 defined by three slots 24a, 24 b and 24 c in the top half 16 a of the biopsy device body 16. Thesecond lever 22, includes first and second openings 26, 28, whichfacilitate mechanical coupling of the larger firing button 14 (see FIG.12B) to the second lever 22. Because of the three slots 24 a, 24 b, and24 c, the second lever 22 is also pivotally movable into and out of theplane defined by a top surface of the body top half 16 a.

FIGS. 12A and 12B illustrate the mechanical coupling of the largerfiring button 14 to the second lever 22. FIG. 12A is a detailedlongitudinal cross-sectional view of the top half 16 a of the biopsydevice body 16 centered on the second opening 28 in the second lever 22.FIG. 12B depicts the larger firing button 14 mechanically coupled to thesecond lever 22 by first and second hooks 30, 32, which mate with firstand second openings 26, 28, respectively. The first and second hooks 30,32 form interference fits with portions of the body top half 16 a setdefined the first and second openings 26, 28. FIGS. 12A and 12B alsoshow that the bottom surface 35 of the first lever 18 is higher than thebottom surface 38 of the second lever 22.

FIGS. 13A-C illustrate the interaction of the larger firing button 14with the first and second levers 18, 22. FIGS. 13A and 13B show thefirst and second levers 18, 22 before and after installation of thelarger firing button 14. FIG. 13C shows the larger firing button 14 inshadow after it has been mechanically coupled to the second lever 22. Asshown in FIG. 13C, a proximal end 34 of the larger firing button 14overlaps a distal end 36 of the first lever 18. This configuration ofthe larger firing button 14 and the first lever 18 allowsactuation/depression of the larger firing button 14 to actuate the firstlever 18 in addition to the second lever 22.

FIGS. 14A and 14B also illustrate the interaction of the larger firingbutton 14 with the first and second levers 18, 22. FIGS. 14A and 14B arebottom and top views of the portion of the body top half 16 a includingthe first and second levers 18, 22. FIG. 14A also shows first and secondcatches 40, 42 defined on the body top half 16 a, which are configuredto retain inner needle latch 44 and outer cannula latch 46, to therebyarm the inner needle and the outer cannula (not shown), respectively.FIG. 14B shows the inner needle latch 44 and outer cannula latch 46schematically as boxes. The inner needle latch 44 and outer cannulalatch 46 are respectively attached to the inner needle and the outercannula via needle carriage/hub 108 and cannula carriage/hub 102 (seeFIG. 16). FIG. 14B also shows the larger firing button 14 installed andin shadow. FIG. 14B shows that, when the larger firing button isinstalled, the proximal end 34 of the larger firing button 14 overlapsthe distal end 36 of the first lever 18.

FIG. 15 is a detailed perspective view of the portion of the biopsydevice body 16 including the smaller and larger firing buttons 12, 14.FIG. 15 shows that when the larger firing button 14 is notactuated/depressed, there is a gap 48 between a bottom surface of theproximal end of the larger firing button 14 and the top contact surfaceof the distal end 36 of the first lever 18.

In use, the smaller firing button 12 is actuated/depressed to pivot thefirst lever 18, thereby releasing an inner needle latch 44. When theinner needle (not shown) is in an armed/non-fired position, releasingthe inner needle latch 44 fires the inner needle (not shown). On theother hand, when the larger firing button 14 is actuated/depressed, boththe first and second levers 18, 20 are pivoted. The proximal end 34 ofthe larger firing button 14 pivots the first lever 18 by acting on thedistal end 36, thereby releasing the inner needle latch 44. The largerfiring button 14 acts directly on the second lever 22 to pivot it,thereby releasing an outer cannula latch 46. Because the bottom surface35 of the first lever 18 is higher than the bottom surface 38 of thesecond lever 22, actuating/depressing the larger firing button 14 firstacts on first lever 18 and releases the inner needle latch 44, then actson lever 22 and releases the outer cannula latch 46. When both the innerneedle (not shown) and the outer cannula 104 are in their respectivearmed/non-fired positions, sequentially releasing the inner needle latch44 and the outer cannula latch 46 sequentially fires the inner needle(not shown) and the outer cannula 104. When the inner needle (not shown)has been fired (e.g., by actuating/depressing the smaller firing button12) and the outer cannula is in an armed/non-fired position, depressingthe larger firing button 14 fires only the outer cannula 104.

Arming Mechanisms:

FIGS. 16 and 17A-C depict an embodiment of a biopsy device 10, andillustrate the arming mechanism for arming the outer cannula 104 and theinner needle (not shown). This arming mechanism is configured for usewith the biopsy devices 10 depicted in FIGS. 1A, 1B and 4. Those biopsydevices 10 are armed by moving an arming button 110 or arming lever 60(collectively “arming member”) in a proximal direction. The embodimentdepicted in FIGS. 16 and 17A-C may share some components or processsteps with or be identical to other embodiments described above.

FIG. 16 illustrates an assembly for sequentially arming the outercannula 104 and the inner needle (not shown). The assembly includes anarming body 101, having a resilient shaft 100, and which is operablycoupled to an arming button 110 or arming lever 60 (see FIGS. 1A, 1B and4) that is operable by a user. The assembly also includes a cannulacarriage/hub 102 operably coupled to the outer cannula 104. The cannulacarriage/hub 102 includes a cannula strike plate 106 disposed along afirst edge of a travel path of the shaft 100 (adjacent a first recess120 in the shaft 100, which is described below). Further the assemblyincludes a needle carriage/hub 108 operably coupled to the inner needle(not shown). The needle carriage/hub 108 includes a needle strike plate112 disposed along a second opposite edge of the travel path of theshaft 100. When both the outer cannula 104 and inner needle are in theirrespective fired/unarmed positions, the needle strike plate 112 isdisposed distal of the cannula strike plate 106.

The distal edge 114 of the cannula strike plate 106 forms a wedge/rampwith a high end adjacent the first edge of the travel path of the shaft100 and the low end away from the first edge. The distal edge 116 of theneedle strike plate 112 forms a wedge/ramp with a high end adjacent asecond edge of the travel path of the shaft 100 (adjacent a secondrecess 122 in the shaft 100, which is described below) and the low endaway from the second edge. As shown in FIG. 16, the distal edge 116 ofthe needle strike plate 112 is positioned more distally than the distaledge 114 of the cannula strike plate 106.

The proximal end 118 of the shaft 100 is enlarged forming first andsecond recesses 120, 122 (collectively a “catch”) configured to receivethe respective distal edges 114, 116 of the cannula strike plate 106 andthe needle strike plate 112. The first recess 120, formed along thefirst edge of the travel path of the shaft 100 and configured to receivethe distal edge 114 of the cannula strike plate 106, is disposed moreproximally along the travel path of the shaft 100 than the second recess122. The axial distance between the first and second recesses 120, 122is greater than the axial distance between the distal edges 114, 116 ofthe cannula and needle strike plates 106, 112. Accordingly, as the shaft100 and its proximal end 118 travel proximally along its travel path,the first recess 120 is configured to receive the distal edge 114 of thecannula strike plate 106 before the second recess 122 receives thedistal edge 116 of the needle strike plate 112.

In use, when both the inner needle (not shown) and the outer cannula 104are in their respective fired/unarmed positions, the user appliesproximally directed force to the shaft 100 by actuating/depressing thearming button 110 or arming lever 60 (see FIGS. 1A, 1B and 4). Theproximally directed force moves the shaft 100 proximally in thedirection shown in FIG. 17A along the travel path for the shaft 100using a compressive arming stroke. Each movement of the shaft 100between opposite ends of the travel path and back is a “stroke.” Duringa first stroke, the first recess 120, which is formed proximally on theproximal end 118 of the shaft 100, first encounters the distal edge 114of the cannula strike plate 106. As shown in FIG. 17A, when the firstrecess 120 contacts the distal edge 114 of the cannula strike plate 106,the resistive force exerted by the wedge/ramp in distal edge 114redirects the proximally directed force laterally, thereby pulling theproximal end 118 of the shaft 100 laterally toward the cannula strikeplate 106 and away from the needle strike plate 112.

As shown in FIG. 17B, when the distal edge 114 of the cannula strikeplate 106 is received in the first recess 120, the proximal end 118 ofthe shaft 100 is pulled laterally away from the needle strike plate 112.At this point, proximal movement of the cannula strike plate 106 and thecannula carriage/hub 102 continues as the spring force resisting same isovercome. As shown in FIG. 17C, the lateral movement of the proximal end118 of the shaft 100 allows the shaft 100 and the cannula carriage/hub102 attached thereto (via the cannula strike plate 106) to moveproximally without the proximal end 118 of the shaft 100 engaging theneedle strike plate 112. During the first stroke, a cannula latch (notshown) on the cannula carriage/hub 102 engages a first catch (not shown)and locks the cannula carriage/hub 102, and the outer cannula 104, intheir armed position.

The user then releases the arming button 110 or arming lever 60 (seeFIGS. 1A, 1B and 4), which is reset distally by an arming button biasingspring (not shown, but see FIG. 26 for a similar spring) disposedbetween the arming button 110 and the proximal end of the biopsy devicebody 16. Next the user again applies proximally directed force to thearming button 110 or arming lever 60 (see FIGS. 1A, 1B and 4) toinitiate a second stroke. With the cannula carriage/hub 102 locked inits armed position, the proximal end 118 of the shaft 100 engages thedistal edge 116 of the needle strike plate 112 during the second stroketo arm the inner needle (not shown) as described above for the outercannula 104.

While the cannula and needle strike plates 106, 112 depicted in FIGS. 16and 17A-C form wedges/ramps, the cannula and needle strike plates 106,112 can take any form. While the cannula and needle strike plates 106,112 depicted in FIGS. 16 and 17A-C are offset from the middle of thelongitudinal axis along the travel path for the shaft 100 (while beinglongitudinally aligned with the first and second recesses 120,122 whenis shaft 100 is not deflected), the cannula and needle strike plates106, 112 can be disposed along the middle of the longitudinal axis. Theform and location of the cannula and needle strike plates 106, 112 canvary as long as they are configured to cooperate with respective firstand second recesses 120, 122 such that when the first recess 120 engagesthe cannula strike plate 106, the proximal end 118 of the shaft 100 ismoved so that the second recess 122 does not engage the needle strikeplate 112 during that stroke.

FIGS. 18-20 depict two similar embodiments of shafts 100 havingdifferent proximal ends 118 from the embodiment depicted in FIGS. 16 and17A-C. In the embodiment shown in FIG. 18, the first and second recesses120, 122 each form a wedge/ramped surface that is configured to twistthe proximal end 118 of the shaft 100 about it longitudinal axis whenurged axially against the respective distal edges 114, 116. In theembodiment shown in FIGS. 19 and 20, the first and second recesses 120,122 each form a helically twisting two-dimensional surface having ahelically twisting trough/guide 124 that is configured to twist theproximal end 118 of the shaft 100 about its longitudinal axis when urgedproximally against the respective distal edges 114, 116. For use withthe embodiments depicted in FIGS. 18-20, the distal edges 114, 116 ofthe cannula and needle strike plates 106, 112 (not shown) can each forma wedge/ramped surface, or other surface configured to interact therespective first and second recesses 120, 122, as described above. Forinstance, for use with the embodiment depicted in FIGS. 18-20, thedistal edges 114, 116 of the cannula and needle strike plates 106, 112(not shown) can each form a point configured to enter into and travelalong the troughs/guides 124 of the respective first and second recesses120, 122.

For use of the embodiment shown in FIG. 18, when the distal edge 114 ofthe more distally disposed cannula strike plate 106 contacts theproximally moving proximal end 118 of the shaft 100, the helicallytwisting two-dimensional surface and the helically twisting trough/guide124 of the first recess 120 interacts with the distal edge 114 to twistthe proximal end 118 of the shaft 100. As a result of this twistingmotion, the proximal end 118 of the shaft 100 does not engage the distaledge 116 of the needle strike plate 112 during a first stroke when boththe inner needle (not shown) and the outer cannula 104 are in theirrespective fired/unarmed positions. On a second stroke, the cannulacarriage/hub 102 is locked in its armed position, the proximal end 118of the shaft 10 bypasses the cannula strike plate 106, and the proximalend 118 of the shaft 100 contacts the distal edge 116 of the needlestrike plate 112 to arm the inner needle (not shown).

For use of the embodiment shown in FIGS. 19 and 20, when the distal edge114 of the more distally disposed cannula strike plate 106 contacts theproximally moving proximal end 118 of the shaft 100, the wedge/rampedsurface of the first recess 120 interacts with the distal edge 114 totwist the proximal end 118 of the shaft 100. As a result of thistwisting motion, the proximal end 118 of the shaft 100 does not engagethe distal edge 116 of the needle strike plate 112 during a first strokewith both the inner needle (not shown) and the outer cannula 104 are intheir respective fired/unarmed positions. On a second stroke, thecannula carriage/hub 102 is locked in its armed position, the proximalend 118 of the shaft 10 bypasses the cannula strike plate 106, and theproximal end 118 of the shaft 100 contacts the distal edge 116 of theneedle strike plate 112 to arm the inner needle (not shown).

FIGS. 21A-25B depict an arming mechanism according to another embodimentthat is configured for use with the biopsy device 10 depicted in FIGS.2A, 2B and 5. Those biopsy devices 10 are armed by relative motionbetween an arming button (or “arming member”) 110 and a biopsy devicebody 16. For instance, the devices 10 can be armed by (1) moving thearming button 110 in a distal direction while keeping the biopsy devicebody 16 stationary; (2) moving the biopsy device body 16 in a proximaldirection while keeping the arming button 110 stationary; or (3) movingthe arming button 110 in a distal direction while moving the biopsydevice body 16 in a proximal direction. The embodiment depicted in FIGS.21A-25B may share some components or process steps with or be identicalto other embodiments described above.

FIG. 21B illustrates an assembly for sequentially arming the outercannula 104 and the inner needle (not shown). The assembly includes anarming body 101 including, or operably coupled to, an arming button 110that is operable by a user. The arming body 101 includes cannula andneedle notches 132, 134, which are configured to retain cannula andneedle carriages/hubs 102, 108 in their respective proximal/armedpositions. The assembly also includes a resilient shaft 100 extendingproximally from the distal end of the biopsy device body 16 (see FIG.21A). The proximal end 118 of the resilient shaft 100 takes the form ofa “Y” having first and second proximally and orthogonally extending arms136, 138, which are configured to interact with the cannula and needlecarriages/hubs 102, 108. The arming body 101 (attached to the armingbutton 110) and the resilient shaft 100 (attached to the biopsy devicebody 16) are located and different depths in the biopsy device 10, suchthat the arming body 101 and the resilient shaft 100 can partiallyoverlap each other during the arming process. The cannula and needlecarriage/hubs 102, 108 span the depths at which the arming body 101 andthe resilient shaft 100 are disposed, and therefore can interact witheach of the arming body 101 and the resilient shaft 100.

The cannula carriage/hub 102 is operably coupled to the outer cannula104. The cannula carriage/hub 102 includes a cannula strike surface 140disposed along a first edge of a travel path of the shaft 100 and thedepth level of the resilient shaft 100 (see FIG. 21A). At the depthlevel of the arming body 101, the cannula carriage/hub 102 includes acannula catch 142 configured to operatively couple to the arming body101 via the cannula notch 132. The cannula carriage/hub 102 alsoincludes a cannula spring holder 144 configured to compress a cannulafiring (or “biasing”) spring 146 against a proximal end of the biopsydevice body 16.

The needle carriage/hub 108 is operably coupled to the inner needle (notshown). The needle carriage/hub 108 includes a needle strike surface 148disposed along a second opposite edge of the travel path of the shaft100 and the depth level of the resilient shaft 100 (see FIG. 21A). Atthe depth level of the arming body 101, the needle carriage/hub 108includes a needle catch 150 configured to operatively couple to thearming body 101 via the needle notch 134. The needle carriage/hub 108also includes a needle spring holder 152 configured to compress a needlefiring (or “biasing”) spring 154 against a proximal end of the biopsydevice body 16.

When both the outer cannula 104 and inner needle are in their respectivefired/unarmed positions, the cannula strike surface 140 is disposeddistal of the needle strike surface 148. The distal edge of the cannulastrike surface 140 forms a wedge/ramp with a high end adjacent the firstedge of the travel path of the shaft 100 and the low end away from thefirst edge. The distal edge of the needle strike surface 148 forms awedge/ramp with a high end adjacent a second edge of the travel path ofthe shaft 100 and the low end away from the second edge. As shown inFIG. 21A, the distal edge of the needle strike surface 148 is positionedmore proximally than the distal edge of the cannula strike surface 140.

The cannula strike surface 140 along the first edge of the travel pathof the shaft 100 is configured to cooperate with the first arm 136 ofthe resilient shaft 100. The needle strike surface 148 along the secondedge of the travel path of the shaft 100 is configured to cooperate withthe second arm 138 of the resilient shaft 100. The distal edge of theneedle strike surface 148 is positioned more proximally than the distaledge of the cannula strike surface 140. Accordingly, with both the outercannula 104 and inner needle are in their respective fired/unarmedpositions, as the shaft 100 and its proximal end 118 travel proximallyalong its travel path, the first arm 136 interacts with the cannulastrike surface 140 before the second arm 138 interacts with the needlestrike surface 148.

In use, when both the inner needle 156 and the outer cannula 104 are intheir respective fired/unarmed positions, the user applies proximallydirected force to the shaft 100 by actuating/depressing the armingbutton 110 (see the transition from FIGS. 21A and 21B to FIGS. 22A and22B), or depressing the biopsy device body 16 with the arming button1/10 secured against a stable surface. Both these motions move thebiopsy device body 16, and the resilient shaft 100 attached thereto,proximally relative to the arming button 110, using a compressive armingstroke. The proximally directed force moves the shaft 100 proximally inthe direction shown in FIG. 21A along the travel path for the shaft 100.Each movement of the shaft 100 between opposite ends of the travel pathand back is a “stroke.”

During a first stroke, the cannula strike surface 140, which ispositioned distally relative to the needle strike surface 148, firstencounters the first arm 136 at the proximal end 118 of the resilientarm 100. When the first arm 136 contacts the distal edge of the cannulastrike surface 140, the resistive force exerted by the wedge/ramp indistal edge 114 redirects the proximally directed force laterally,thereby pulling the proximal end 118 of the shaft 100 laterally towardthe cannula strike surface 140 and away from the needle strike surface148, such that the second arm 138 does not interact with the needlestrike surface 148 on the first stroke.

As the stroke continues, proximal movement of the cannula strike surface140 and the cannula carriage/hub 102 compresses the cannula firingspring 146. In the middle of the first stroke, the cannula catch 142 isdisposed in the cannula notch 132 in the arming body 101, and locks thecannula carriage/hub 102 and the outer cannula 104, in their armedposition (see FIG. 23B).

The user then releases the arming button 110 or biopsy device body 16,which is reset proximally (arming button 110) or distally (biopsy devicebody 16) by an arming button biasing spring (not shown, but see FIG. 26for a similar spring) (see FIGS. 23A and 23B). Next the user againapplies distally directed force to the arming button 110 (relative tothe biopsy device body) or proximally directed force to the biopsydevice body 16 (relative to the arming button 110) (see FIGS. 24A and24B) to initiate a second stroke. With the cannula carriage/hub 102locked in its armed position, the proximal end 118 of the shaft 100engages the needle strike surface 148 during the second stroke to armthe inner needle 156 as described above for the outer cannula 104. Asthe second stroke continues, proximal movement of the needle strikesurface 148 and the needle carriage/hub 108 compresses the needle firingspring 154. During the second stroke, the needle catch 150 is disposedin the needle notch 134 in the arming body 101 and locks the needlecarriage/hub 108, and the inner needle 156, in their armed position (seeFIG. 24B). The user then releases the arming button 110 or biopsy devicebody 16, which is reset proximally by a spring (see FIGS. 25A and 25B).

While the cannula and needle strike surfaces 140, 148 depicted in FIGS.21A-25B form wedges/ramps, the cannula and needle strike surfaces 140,148 can take any form, as described above. While the cannula and needlestrike surfaces 140, 148 depicted in FIGS. 21A-25B are offset from themiddle of the longitudinal axis of the shaft 100 (while beinglongitudinally aligned with the first and second arms 136,138 when isshaft 100 is not deflected), the cannula and needle strike surfaces 140,148 can be disposed along the middle of the longitudinal axis. The formand location of the cannula and needle strike surfaces 140, 148 can varyas long as they are configured to cooperate with respective first andsecond arms 136, 138 such that when the first arm 136 engages thecannula strike surface 140, the proximal end 118 of the shaft 100 ismoved so that the second arm 138 does not engage the needle strikesurface 148 during that stroke. Further, the form and location of theproximal end 118 of the resilient shaft 100 can vary as long as itincludes features (e.g., first and second arms 136, 138) configured tocooperate with respective cannula and needle strike surfaces 140, 148,as described above. For instance, the proximal end 118 of the resilientshaft 100 may be similar to the proximal end 118 depicted in FIG. 16.

FIG. 26 depicts another embodiment of a biopsy device 10 (similar to onedepicted in FIG. 1A) including an arming mechanism having a resilientshaft 100 that forms first and second arms 136, 138 at a distal end 158thereof. The embodiment depicted in FIG. 26 functions similarly to theembodiments depicted in FIGS. 16, 17A-C and 21A-25A. The embodimentdepicted in FIG. 26 shows an arming button biasing spring 160 disposedbetween the arming button 110 and the proximal end of the biopsy devicebody 16, and configured to return the button between arming strokes.

Removing Tissue from Biopsy Device:

Spring loaded core biopsy devices 10 are used to remove a sample oftissue from the patient for pathology (e.g., to determine whethercancerous cells are present). Typical spring loaded core devices 10 havea needle 202 with an aperture 206 (e.g., a slot) cut into it, and theneedle 202 is disposed coaxially within a cutting cannula 204 having asharpened distal edge 208. During a biopsy, the tissue prolapsed intothe aperture 206 is severed by the cannula 204 as the cannula 204translates over the aperture 206, forming a core of excised tissue 210.The cannula 204 is then retracted, exposing the excised tissue 210contained in the aperture 206. The tissue is then removed from theaperture 206 and placed in fixative and analyzed.

There are several known methods for removing the excised tissue 210 fromthe aperture 206, including scraping the needle against an edge or theinterior of a collection container, picking up with forceps anddepositing into a collection container, shaking or tapping of the needleto dislodge the excised tissue 210 into a collection container, orwiping the tissue specimen onto a piece of gauze and depositing into acollection container. Known methods for removing the excised tissue 210from the aperture 206 can be time-consuming, but the excised tissue 210must be removed from the aperture 206 before additional tissue can bebiopsied. Further, all of the above-described known methods riskdropping or otherwise contaminating the excised tissue core 210 duringtransfer into the collection container.

FIGS. 27-31 illustrate various embodiments for removing excised tissue210 from the aperture 206 of a spring loaded core device 10. FIG. 27depicts an embodiment of a spring loaded core device 10 in which theaperture 206 in the needle 202 is coated with a lubricious material 212that resists adherence of the tissue to the aperture. Fatty tissue isthe typical tissue that adheres to the aperture 206 in metallic needles202. Accordingly, the lubricious material 212 coating may be oleophobic,hydrophobic, or both.

FIGS. 28 and 29 depict another embodiment in which the spring loadedcore device 10 includes a pushing device 214 configured to remove theexcised tissue core 210 from the aperture 206 by mechanically pushingand/or scraping. The pushing device 214 includes a scoop, spatula, orother shaped body 216 disposed in the aperture 206 and having a proximalend coupled to an elongate body 218 (e.g., a thin wire), which runsalong the length of the spring loaded core device 10 in an annular space220 between the needle 202 and the cannula 204. As shown in FIG. 29, thescoop/spatula/shaped body 216 can be advanced distally using theelongate body 218 to dislodge/eject the excised tissue core 210 from theaperture 206. After dislodging or ejecting the excised tissue core 210,the scoop/spatula/shaped body 216 can be retracted into the annularspace 220. Alternatively, the scoop/spatula/shaped body 216 can sit(substantially flush) against the proximal end of the aperture 206 whennot in use.

FIGS. 30 and 31 depict two related embodiments of spring loaded coredevices 10 that use a flushing fluid 222, such as saline, to flush theexcised tissue core 210 from the aperture 206 and into a collection vial(not shown). In the embodiment depicted in FIG. 30, the flushing fluid222 is pushed distally through the spring loaded core device 10 in theannular space 220 between the needle 202 and the cannula 204. A port(not shown) on the spring loaded core device 10 can be attached to asyringe (not shown) filled with the flushing fluid 222 to provide theflushing fluid 222 under pressure. In the embodiment depicted in FIG.31, the flushing fluid 222 is pushed distally through the spring loadedcore device 10 in the lumen 224 of a hollow needle 202. This embodimentprovides a more direct flow of the flushing fluid 222 into the aperture206 to flush the excised tissue core 210 therefrom.

Although particular embodiments of the disclosed inventions have beenshown and described herein, it will be understood by those skilled inthe art that they are not intended to limit the present inventions, andit will be obvious to those skilled in the art that various changes andmodifications may be made (e.g., the dimensions of various parts)without departing from the scope of the disclosed inventions, which isto be defined only by the following claims and their equivalents. Thespecification and drawings are, accordingly, to be regarded in anillustrative rather than restrictive sense. The various embodiments ofthe disclosed inventions shown and described herein are intended tocover alternatives, modifications, and equivalents of the disclosedinventions, which may be included within the scope of the appendedclaims.

What is claimed is:
 1. A biopsy device for percutaneous tissue removal,comprising: an elongated housing having an operational axis; a stylethub slidably mounted in the housing, wherein the stylet hub is movablerelative to the housing between a proximal, armed position, and adistal, fired position; a cannula hub slidably mounted in the housingalongside the stylet hub, wherein the cannula hub is movable relative tothe housing between a proximal, armed position, and a distal, firedposition; and a spring-biased arming member moveably mounted to thehousing proximal of the respective stylet and cannula hubs, the armingmember configured for manually-actuated movement from a relaxed,extended position to a loaded, compressed position to define acompressive arming stroke, wherein an arming member biasing springrestores the arming member from the compressed position to the extendedposition, the arming member having a surface configured to be depressedproximally relative to the housing to thereby move the arming memberfrom the extended position into an interior of the housing forcompleting the compressive arming stroke, wherein the arming membersurface is proximal of the cannula and stylet hubs.
 2. The biopsy deviceof claim 1, the stylet hub having a stylet strike laterally offset fromthe operational axis in a first lateral direction, the cannula hubhaving a cannula strike laterally offset from the operational axis in asecond lateral direction, and proximal of the stylet strike, when thestylet hub and cannula hub are in the fired position.
 3. The biopsydevice of claim 2, further comprising a resilient arming shaft coupledto the arming member and extending along the operational axis, whereinthe resilient shaft is integrally formed with or attached to an armingshaft catch, wherein the arming shaft catch, when the stylet hub andcannula hub are each in the fired positions, is configured to engage thecannula strike, upon a first compressive arming stroke, to therebydeflect the arming shaft catch away from the operational axis such thatthe arming shaft catch clears the stylet strike and moves the cannulahub to the armed position, and wherein the arming shaft catch isconfigured to engage the stylet strike, upon a second compressive armingstroke, to move the stylet hub to the armed position.
 4. The biopsydevice of claim 3, the arming shaft catch comprising a first recesshaving an angled engagement surface configured to receive the cannulastrike during the first compressive arming stroke, and a second recesshaving an angled engagement surface configured to receive and engage thestylet strike during the second arming stroke.
 5. The biopsy device ofclaim 4, further comprising: a stylet having a proximal end portioncoupled to the stylet hub, and a tissue piercing distal portionextending beyond a distal end of the housing, the stylet hub beingbiased by a stylet hub biasing spring toward the distal end of thehousing for driving the stylet in a distal direction relative to thehousing, the stylet hub having a stylet hub catch for releasablyretaining the stylet hub in the armed position; and a cannula having aproximal end portion coupled to the cannula hub, the cannula beingdisposed coaxially around the stylet and having an open-ended distalportion extending beyond the distal end of the housing, the cannula hubbeing biased by a cannula hub biasing spring toward the distal end ofthe housing for driving the cannula over the stylet in a distaldirection relative to the housing, the cannula hub having a cannula hubcatch for releasably retaining the cannula hub in the armed position. 6.The biopsy device of claim 5, the housing comprising a first deflectablewall portion, wherein, when the stylet hub is in the armed position,deflecting the first wall portion releases the stylet hub catch, causingthe stylet hub spring to propel the stylet hub to the fired position,and a second deflectable wall portion of the housing, wherein, when thecannula hub is in the armed position, deflecting the second wall portionreleases the cannula hub catch, causing the cannula hub spring to propelthe cannula hub to the fired position, the second deflectable wallportion being separated from the first deflectable wall portion so thatdeflection of the first wall portion does not release the cannula hubcatch, and deflection of the second wall portion does not release thestylet hub catch, the biopsy device further comprising: a first controlpushbutton comprising or coupled to the first deflectable wall portion;and a second control pushbutton coupled to the housing at leastpartially over the first wall portion and at least partially over thesecond wall portion, wherein, when the stylet hub and cannula hub areeach in the armed position, depressing the second control pushbuttonsequentially deflects the first and second wall portions, therebysequentially releasing the stylet hub catch and the cannula hub catch,to thereby sequentially propel the respective stylet and cannula in thedistal direction.
 7. The biopsy device of claim 6, wherein the secondcontrol push button is attached or fixed to the first wall portion, andspaced apart from the second wall portion by a gap, such that depressingthe second control pushbutton substantially simultaneously deflects thefirst wall portion while not deflecting the second wall portion untilthe second control button is depressed through the gap to make contactwith the second wall portion.
 8. The biopsy device of claim 1, thearming member surface being sized and configured for being manuallydepressed into the proximal portion of the housing using one or morefingers of a single hand, the housing having a proximal end surfacesized and configured for being retained against a palm of the singlehand when the arming member surface is depressed, such that thecompressive arming stroke can be made by backstopping the proximal endsurface in the palm and squeezing the arming member into the proximalhousing portion using the at least one finger, respectively, of thehand.